PRINCETON, N.J. The Food and Drug Administration has approved a new dose of a treatment for hemophilia from Novo Nordisk, the Danish drug maker said.
The FDA approved Novo Nordisk’s NovoSeven RT (coagulation factor VIIa [recombinant], room temperature stable) in 8-mg vials. The treatment, which comes in the form of a powder mixed for injection, was already available in 1, 2 and 5 mg vials. The FDA also approved an extension of shelf life for all vial sizes from 24 months to 36 months at or below 77 degrees.
NovoSeven RT is formulated for patients with hemophilia A or B with inhibitors. The new dosage will shorten the time it takes to prepare the injection, known as reconstitution, compared with current dosages.